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Recruiting NCT07268638

A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)

Phase II Interventional Focal Segmental Glomerulosclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Praliciguat, Placebo.
Who it may be relevant to
Registry conditions: Focal Segmental Glomerulosclerosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Praliciguat in Patients With Biopsy-Confirmed Focal Segmental Glomerulosclerosis

Overview

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of praliciguat in adults with biopsy-confirmed focal segmental glomerulosclerosis (FSGS). Participants will be randomized 1:1 to receive praliciguat or placebo for initial 24 week treatment period. Following this double-blind period, all participants will receive praliciguat in an open-label extension for an additional 24 weeks.

Interventions

  • Drug Praliciguat
    Oral Tablet
  • Other Placebo
    Oral Tablet

Primary outcome measures

  • Change from Baseline in urine protein-to-creatinine ratio (UPCR) [Time frame: Baseline (Day 1) and up to Week 24]
Secondary outcome measures (2)
  • Percentage of Participants with Partial Remission at Week 24 [Time frame: Up to Week 24]
  • Plasma concentrations of praliciguat [Time frame: Week 24, Week 32, and Week 36]

Eligibility criteria

Inclusion criteria

  • UPCR ≥1 (g/g) during screening.
  • On maximally tolerated ACEi or ARB per principal investigator discretion within 1 month of informed consent.
  • Estimated glomerular filtration rate ≥25 milliliters per minute per 1.73 square meters by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
  • Kidney biopsy collected within 5 years of screening consistent with FSGS or kidney biopsy collected ≥5 years prior to screening consistent with FSGS plus the presence of a pathogenic gene mutation known to be associated with FSGS.

Exclusion criteria

  • Collapsing FSGS in the kidney biopsy report.
  • Sickle cell disease.
  • HbA1c >8%.
  • Uncontrolled hypertension (≥160/100 millimeters of mercury).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 23 centers
  • Investigator Site #2 — Chula Vista
  • Investigator Site #14 — Los Angeles
  • Investigator Site #12 — San Dimas
  • Investigator Site #13 — Arvada
  • Investigator Site #17 — Boca Raton
  • Investigator Site #6 — Coral Springs
  • Investigator Site #7 — Miami
  • Investigator Site #8 — Orlando
  • … and 15 more centers

Identifiers

NCT: NCT07268638 · AKB-1973-CI-0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗